CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
GM-CSF, sargramostimdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologic or cytologic diagnosis of primary ovarian, primary peritoneal, or tubal carcinoma
  • ✓Asymptomatic from cancer
  • ✓Evidence of recurrent disease: CA-125 >35 U/mL or two successive rising values with most recent ≥3× nadir, OR evaluable/measurable disease on imaging
  • ✓Age >18 years
Key exclusion· 8
  • ✕Known severe hypersensitivity to GM-CSF
  • ✕Other coexisting malignancies or malignancies diagnosed within last 5 years (except basal cell carcinoma, cervical cancer in situ, or concurrent superficial or stage IB endometrial carcinoma)
  • ✕Concomitant antineoplastic or investigational therapy
  • ✕Treatment with non-FDA approved or investigational drug within 30 days before Day 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00157573
NCT00157573Phase 2Completed
CompareCT.gov

Phase II Trial of GM-CSF in Women With Asymptomatic Ovarian, Primary Peritoneal, or Tubal Carcinoma

Massachusetts General Hospital·interventional·Posted Sep 12, 2005·Updated May 8, 2017

In Brief

A Phase 2 clinical trial evaluating GM-CSF, sargramostim for Ovarian Cancer and Fallopian Tube Cancer. Completed, enrolled 72 participants.

Detailed Summary

Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Fallopian Tube Cancer
Countries--
CollaboratorsDana-Farber Cancer Institute, Bayer

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartDec 1, 2004
Primary CompletionOct 1, 2008
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

GM-CSF, sargramostimdrug

GM-CSF subcutaneous injection